Hydroxychloroquine Sulfate
- Product NDC
- 16729-562
- 11-digit product format
- 167290562
- Labeler code
- 16729
- Product ID
- 16729-562_4e68b971-e226-d3ff-e063-6294a90ae772
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.,
- Application
- ANDA213342
- Marketing category
- ANDA
- Marketing start
- 2021-09-28
- Substance
- HYDROXYCHLOROQUINE SULFATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydroxychloroquine Sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYCHLOROQUINE SULFATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8Q2869CNVH |
| Rxcui | 979092, 1119312, 2569281, 2569283 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-562-01 | Hydroxychloroquine Sulfate | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-562 | HYDROXYCHLOROQUINE SULFATE TABLET [ACCORD HEALTHCARE, INC.,] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240718_84b00366-96ef-41e1-bac6-5d24acdb9e1d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-562-01 | 16729056201 | 100 TABLET in 1 BOTTLE (16729-562-01) | 100 tablet | 2021-09-28 | 0000-00-00 | No | No | Current |